NMI MICROCATHETER


Device Classification Name

catheter, intravascular, diagnostic

510(k) Number K121954
Device Name NMI MICROCATHETER
Applicant
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Applicant Contact wanda carpinella
Correspondent
NAVILYST MEDICAL, INC.
26 forest street
marlborough, 
MA 
01752

Correspodent Contact wanda carpinella
Regulation Number 870.1200
Classification Product Code
DQO  
Date Received 07/03/2012
Decision Date 07/17/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No